מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
IBUPROFEN
Clonmel Healthcare Ltd
400 Milligram
Film Coated Tablet
2011-09-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Easofen Max Strength 400 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg ibuprofen. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Round, white, biconvex film-coated tablets, 12 mm in diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the short term management of muscular pain, backache, dental pain and dysmenorrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over the age of 12 years: The usual dose is 400 mg and subsequently if necessary 400 mg every four to six hours with a maximum of 1200 mg in a twenty-four hour period. Not recommended in children under the age of 12 years. Elderly NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed (see also section 4.4). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Route of administration Oral. 4.3 CONTRAINDICATIONS History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding or other gastrointestinal disorder). Patients with a known history of hypersensitivity reactions (e.g., bronchospasm, rhinitis or urticaria) in response to ibuprofen (the active substance or any of the excipients in Easofen Max Strength, aspirin or other non-steroidal anti- inflammat קרא את המסמך השלם